Full Press Release Details
Bicycle Therapeutics Reports Third Quarter
2020 Financial Results and Provides Corporate Update
- Three clinical trials of novel Bicycles initiated this quarter, including a Phase IIa for BT1718, a Phase I for BT8009, and a Phase II for THR-149
- Cash was $149.8 million at September 30, 2020, which includes net proceeds received during Q3 from completion of $50.0 million at-the-market (ATM) offering program and initial $15.0 million drawn from debt financing
- Corporate leadership strengthened with key appointments to Scientific Advisory Board and senior management team
England, & BOSTON, November 5, 2020 - Bicycle Therapeutics plc
(NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic
peptide (Bicycles ) technology, today reported financial results
for the third quarter ended September 30, 2020 and discussed recent corporate updates.
"Amidst the uncertainty brought on by the COVID-19
pandemic, Bicycle has made significant advances during the third quarter, including the initiation of dosing in a Phase IIa
trial of BT1718, in a Phase I/II trial of BT8009, and in Oxurion's Phase II study of THR-149," said Kevin Lee,
Ph.D., Chief Executive Officer of Bicycle Therapeutics. "As we advance and expand our clinical portfolio, with multiple
potential inflection points in the coming year, we have thoughtfully bolstered our balance sheet through our ATM program and
the closing of a non-dilutive debt financing. We have also enhanced Bicycle's clinical leadership with the appointment
of Dominic Smethurst as Chief Medical Officer and the addition of prominent scientists and clinicians to our Scientific
Advisory Board, now chaired by renowned immunologist Sir Keith Peters. We believe we are well-positioned as we pursue our
goal of realizing the full potential of our disruptive Bicycle technology."
Third Quarter 2020 and Recent Highlights
Upcoming Investor Presentations
Bicycle will present at the following
investor conferences in the fourth quarter of 2020. The conferences will be held in a virtual meeting format:
A live webcast of each presentation
will be accessible in the Investors & Media section of Bicycle's website at bicycletherapeutics.com. Archived replays
of the webcasts will be available for 90 days following the presentation dates.
About Bicycle Therapeutics
Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred
to as Bicycles , for diseases that are underserved by existing therapeutics. Bicycles are
fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry.
This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates
for drug development. Bicycle's lead product candidate, BT1718, a Bicycle Toxin Conjugate (BTC) that targets
MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial in collaboration with the Centre for Drug Development
of Cancer Research UK. Bicycle is also evaluating BT5528, a second-generation BTC targeting EphA2, in a Company-sponsored Phase
I/II study. BT8009 is a BTC targeting Nectin-4, a well-validated tumor antigen, and is also currently being evaluated a Company-sponsored
Phase I/II trial. Bicycle is headquartered in Cambridge, UK with many key functions and members of its leadership team
located in Lexington, MA. For more information, visit bicycletherapeutics.com.
Forward Looking Statements
This press release may contain forward-looking statements made
pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified
by words such as "aims," "anticipates," "believes," "could," "estimates,"
"expects," "forecasts," "goal," "intends," "may," "plans,"
"possible," "potential," "seeks," "will" and variations of these words or similar
expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these
words. Forward-looking statements in this press release include, but are not limited to, statements regarding Bicycle's anticipated
advancement and expansion of its clinical pipeline, the application of the Bicycle platform to address the ongoing COVID-19 pandemic
or other viral threats, anticipated enrollment in and progression of Bicycle's and its collaborator's clinical trials,
the therapeutic potential of Bicycle's product candidates; the availability of future funding under Bicycle's debt
facility with Hercules Capital, Inc., and Bicycle's ability to achieve planned milestones. Bicycle may not actually achieve
the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on
these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations
disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial
commencement, patient enrollment and follow-up, as well as to Bicycle's and its collaboration partners' abilities to
meet other anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; uncertainties inherent in the initiation
and completion of preclinical studies and clinical trials and clinical development of Bicycle's product candidates by Bicycle
or its collaboration partners; the risk that Bicycle may not realize the intended benefits of its technology; availability and
timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive
of clinical trial results; the risk that trials and studies may be delayed and may not have satisfactory outcomes; expectations
for regulatory approvals to conduct trials or to market product; the risk that Bicycle may not satisfy certain conditions precedent
to the availability of additional borrowings under its debt facility with Hercules Capital; and other important factors, any of
which could cause Bicycle's actual results to differ from those contained in the forward-looking statements, are described
in greater detail in the section entitled "Risk Factors" in Bicycle's Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission (SEC) on August 5, 2020, as well as in other filings Bicycle may make with the SEC in the
future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle expressly
disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information,
future events, changed circumstances or otherwise, except as otherwise required by law.
Bicycle Therapeutics plc
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share and per share
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Collaboration revenues | $ | 3,842 | $ | 614 | $ | 6,542 | $ | 8,520 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 7,363 | 6,078 | 23,091 | 18,891 | ||||||||||||
| General and administrative | 7,154 | 4,789 | 18,351 | 11,164 | ||||||||||||
| Total operating expenses | 14,517 | 10,867 | 41,442 | 30,055 | ||||||||||||
| Loss from operations | (10,675 | ) | (10,253 | ) | (34,900 | ) | (21,535 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income, net | 72 | 440 | 655 | 594 | ||||||||||||
| Other expense, net | - | - | - | (5,377 | ) | |||||||||||
| Total other expense, net | 72 | 440 | 655 | (4,783 | ) | |||||||||||
| Net loss before income tax provision | (10,603 | ) | (9,813 | ) | (34,245 | ) | (26,318 | ) | ||||||||
| Benefit from income taxes | (465 | ) | (331 | ) | (668 | ) | (116 | ) | ||||||||
| Net loss | $ | (10,138 | ) | $ | (9,482 | ) | $ | (33,577 | ) | $ | (26,202 | ) | ||||
| Net loss attributable to ordinary shareholders | $ | (10,138 | ) | $ | (9,482 | ) | $ | (33,577 | ) | $ | (26,202 | ) | ||||
| Net loss per share attributable to ordinary shareholders, basic and diluted | $ | (0.52 | ) | $ | (0.53 | ) | $ | (1.81 | ) | $ | (3.00 | ) | ||||
| Weighted average ordinary shares outstanding, basic and diluted | 19,426,833 | 17,900,978 | 18,504,013 | 8,734,943 |
| September 30, | December 31, | |||||||
| 2020 | 2019 | |||||||
| Cash | $ | 149,842 | $ | 92,117 | ||||
| Working capital | 147,111 | 95,325 | ||||||
| Total assets | 170,059 | 110,194 | ||||||
| Shareholders equity | 109,551 | 93,198 |
Investor and Media Contact:
Bicycle Therapeutics